UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057470 |
|---|---|
| Receipt number | R000065664 |
| Scientific Title | Retrospective observational study in MRI imaging evaluation of ST- segment elevation myocardial infarction (STEMI). |
| Date of disclosure of the study information | 2025/03/31 |
| Last modified on | 2025/03/31 21:58:38 |
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Basic information
Public title
Retrospective observational study in MRI imaging evaluation of ST- segment elevation myocardial infarction (STEMI).
Acronym
Retrospective observational study in MRI imaging evaluation of ST- segment elevation myocardial infarction (STEMI).
Scientific Title
Retrospective observational study in MRI imaging evaluation of ST- segment elevation myocardial infarction (STEMI).
Scientific Title:Acronym
Retrospective observational study in MRI imaging evaluation of ST- segment elevation myocardial infarction (STEMI).
Region
| Japan |
Condition
Condition
acute myocardial infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A retrospective observational study to evaluate infarct size and prognosis on MRI images of STEMI patients to determine whether infarct size is a useful prognostic factor
Basic objectives2
Others
Basic objectives -Others
Retrospective study to examine prognostic factors
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To investigate the association between cardiac MRI findings and the occurrence of the following composite cardiovascular events: all-cause mortality, cardiovascular-related mortality, heart failure, acute myocardial infarction, unstable angina, coronary revascularization (percutaneous coronary angioplasty, coronary artery bypass graft surgery) and stroke.
Key secondary outcomes
To investigate the association between cardiac MRI findings and the occurrence of each individual cardiovascular event.
To investigate the association between cardiac MRI findings and time from onset to reperfusion.
To investigate the association between infarct size obtained outside of cardiac MRI findings and the occurrence of cardiovascular events.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
STEMI patients underwent primary PCI
Key exclusion criteria
Persons who have refused to participate in this study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Okumura |
Organization
Department of Medicine, Nihon University School of Medicine
Division name
Division of Cardiology
Zip code
173-8610
Address
30-1 Ohyaguchi, Kamicho, Itabashi-Ku, Tokyo, Japan
TEL
03-3972-8111(2412)
okumura.yasuo@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiko |
| Middle name | |
| Last name | Yoshida |
Organization
Nouvelle Place Inc.
Division name
Research Promotion Group
Zip code
105-0001
Address
3-8-21 Toranomon, Minato-ku, Tokyo
TEL
03-6680-2525
Homepage URL
rmo-marketing@n-place.co.jp
Sponsor or person
Institute
Division of Cardiology, Department of Medicine, Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Adriakaim Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University Itabashi Hospital Clinical Research Center
Address
30-1 Oyaguchi-Kami Itabashi-Ku, Tokyo, Japan
Tel
03-3972-8111(3007)
med.itabashi.chiken@nihon-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
日本大学医学部附属板橋病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
334
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective observational study to evaluate infarct size and prognosis on MRI images of STEMI patients to determine whether infarct size is a useful prognostic factor
Management information
Registered date
| 2025 | Year | 03 | Month | 31 | Day |
Last modified on
| 2025 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065664
